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510(k) K060101

ESTECH AORTIC EASY FLOW CANNULA by Endoscopic Technologies, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
January 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Endoscopic Technologies, Inc.

  • K053326 — ESTECH COBRA ELECTROSURGICAL UNIT & CABLE (January 6, 2006)
  • K053100 — ESTECH COBRA BIPOLAR SYSTEM (December 19, 2005)
  • K946105 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (April 6, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K945979 — TROCAR/CANNULA (December 21, 1994)
  • K924057 — DISPOSIBLE ELECTRO COAGULATION PROBE (March 11, 1994)
  • K922685 — TROCARS (April 5, 1993)

Other clearances for product code DWF

  • K250937 — Venous Return Cannulae (March 11, 2026)
  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (February 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)